Role of plant derived essential oils in COVID-19 patient.
Phase 1
Completed
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2021/07/034962
- Lead Sponsor
- Amol N Patil
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 144
Inclusion Criteria
1] Healthy volunteers with normal liver and kidney function, normal hemogram and ECG, urine routine, chest X-ray examination, negative urine drug screen, negative HIV, HCV, HbsAg as assessed by baseline investigations
2] Age between 18 to 55 years
3] Either gender
4] Ready to give consent and willing to undergo experiment and comply with protocol
Exclusion Criteria
1.Age < 18 and > 55 years.
2.Patients with moderate or severe disease.
3.Pregnant and lactating population.
4.Patients not giving consent for the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To assess the safety and determine maximum tolerated dose of Essential oil blend nebulization by evaluating the toxicities including: type, frequency, severity, attribution and duration. <br/ ><br>2.To assess the efficacy of EOs nebulisation in preventing respiratory symptoms development in asymptomatic and mild disease COVID-19 positive patients <br/ ><br>3.To assess the efficacy of EOs nebulisation in respiratory symptom relief in mild disease COVID-19 positive patients. <br/ ><br>Timepoint: Baseline, Day 3, 5, 7, 10 and !4
- Secondary Outcome Measures
Name Time Method 1.To analyse its role in days to clinical recovery and need of hospitalisation. <br/ ><br>2.To analyse time to viral RNA negativity. <br/ ><br>3.To assess its effectiveness in relief of symptoms like anosmia, dysgeusia, pharyngitis in mild disease COVID-19 positive patients. <br/ ><br>Timepoint: Baseline, Day 3, 5, 7, 10 and !4